Lesinurad and Febuxostat Combination Extension Study in Gout
- Registration Number
- NCT01808144
- Lead Sponsor
- Ardea Biosciences, Inc.
- Brief Summary
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.
- Detailed Description
This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with febuxostat in subjects who completed the double-blind treatment period in Study RDEA594-304.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 196
Inclusion Criteria
- Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
- Subject completed the double-blind treatment period in Study RDEA594-304 and was actively receiving and tolerating study medication (lesinurad or placebo) and febuxostat 80 mg at the Month 12 visit.
- Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication.
Exclusion Criteria
- Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lesinurad 200 mg + febuxostat 80 mg lesinurad - lesinurad 200 mg + febuxostat 80 mg febuxostat - lesinurad 400 mg + febuxostat 80 mg febuxostat Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015. lesinurad 400 mg + febuxostat 80 mg lesinurad Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015.
- Primary Outcome Measures
Name Time Method Percentage of Participants With an sUA Level That is < 5.0 mg/dL Up to approximately 2.5 years (at Extension Month 12) Percentage of participants in Study 307 With sUA \< 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases
- Secondary Outcome Measures
Name Time Method Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus Up to approximatley 2.5 years (at Extension Month 12) Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases)